Assessment of a Non-Absorbable Monofilament Suture for Skin Closure in Adults and Paediatrics – Skinda, an International, Bi-Centric, Prospective Cohort Study

Abstract

Each surgical incision has to be closed after surgery. Suture materials are mostly applied which differ in their filament structure, material composition, as well as in their absorption profile, and the choice of the suture material used for skin closure is mainly based on the surgeon´s preference. We designed a prospective, international, multicentric, single-arm, observational study to assess the clinical outcome of a non-absorbable monofilament nylon-based suture for skin closure with a comparison to historic data from the literature. In total, 115 patients were enrolled with an equally distribution of adults and paediatrics receiving a nylon-based suture material to close the skin. Different safety (wound dehiscence, surgical site infections, and adverse events) and effectiveness parameters (pain, wound healing, patient satisfaction, cosmetic result, intraoperative suture handling) were selected to judge the performance of the suture material. The assessment of patient satisfaction, wound healing, and handling properties of the suture was done using a Likert scale, whereas the Patient and Observer Scar Assessment Scale (POSAS) was chosen for aesthetic scar rating. The primary endpoint was a combined rate of wound dehiscence and surgical site infection occurring until suture removal. After discharge, the patients were examined at suture removal and the paediatric population received a further routinely 1-month post-surgery follow-up. Until suture removal, 2 surgical site infections (1.75%) occurred and one wound dehiscence was seen until 30 days postoperatively, indicating significant lower rates compared to historical data. Furthermore, good handling properties of the suture material as well as a high patient satisfaction combined with an excellent wound healing and cosmetic appearance were reported. Based on our findings, it can be concluded that a monofilament nylon-based suture material is an optimal choice for skin closure in adults as well as in children, and it represents an appropriate alternative to other devices, which are currently in utilization.